Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr Recalled by Torrent Pharma Inc Due to cGMP Deviations: Potential product contamination with Burkholderia cepacia...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Torrent Pharma Inc directly.
Affected Products
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Quantity: 262,008 bottles
Why Was This Recalled?
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Where Was This Sold?
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
About Torrent Pharma Inc
Torrent Pharma Inc has 44 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report